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FDA 510(k)

VITERION 100 TELEHEALTH MONITOR

K-Number: K030419 · 2003-11-06

ApplicantViterion Telehealthcare, LLC
Decision Date2003-11-06
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITERION 100 TELEHEALTH MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Viterion Telehealthcare, LLC. It received FDA 510(k) clearance on 2003-11-06 under 510(k) number K030419. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITERION 100 TELEHEALTH MONITOR?

VITERION 100 TELEHEALTH MONITOR is a medical device that received FDA 510(k) clearance on 2003-11-06. The listed applicant is Viterion Telehealthcare, LLC. The 510(k) number is K030419.

When did VITERION 100 TELEHEALTH MONITOR receive FDA 510(k) clearance?

VITERION 100 TELEHEALTH MONITOR received FDA 510(k) clearance on 2003-11-06, under 510(k) number K030419.

Who is the listed applicant for VITERION 100 TELEHEALTH MONITOR?

The FDA 510(k) record lists Viterion Telehealthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITERION 100 TELEHEALTH MONITOR?

The FDA product code for VITERION 100 TELEHEALTH MONITOR is MWI.

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Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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